Assyro AI

Orange Book product · Brand (NDA)

GLUCOTROL XL

GLIPIZIDE

Brand (NDA)NDA 020329DISCN PFIZER
View GLIPIZIDE familyOpen on FDA Orange Book

At a glance

Aug 10, 1999

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 10, 1999

    27 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GLIPIZIDE

Strength

2.5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 020329

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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